Page:United States Statutes at Large Volume 102 Part 4.djvu/1011

 PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3981

sentence, the Secretary may not require that the assay methodology used to determine the withdrawal period of the new animal drug be more rigorous than the methodology used to determine the withdrawal period for the approved new animal drug referred to in the application. If such studies are required and if the approved new animal drug, referred to in the application for the new animal drug for which such studies are required, is approved for use in more than one animal species, such studies shall be conducted for one species, or if the Secretary deems appropriate based on scientific principles, shall be conducted for more than one species.". SEC 102. PATENT INFORMATION.

(a) SECTION 512Q>).—Section 512(b)(l) of such Act is amended by 21 USC 360b. adding at the end the following: "The applicant shall file with the application the patent number and the expiration date of any patent which claims the new animal drug for which the applicant filed the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the information required by the preceding sentence. Upon approval of the application,- the Secretary shall publish Public information. information submitted under the two preceding sentences.". (b) OTHER SECTIONS.—

(1) Section 512(c) is amended by adding at the end the following: "(3) If the patent information described in subsectionflt>Xl)could not be filed with the submission of an application under subsection 0)X1) because the application was filed before the patent information was required under subsection (b)(1) or a patent was issued after the application was approved under such subsection, the holder of an approved application shall file with the Secretary the patent number and the expiration date of any patent which claims the new animal drug for which the application was filed or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of an approved application could not file patent information under subsection QJXI) because it was not required at the time the application was approved, the holder shall file such information under this subsection not later than 30 days after the date of the enactment of this sentence, and if the holder of an approved application could not file patent information under subsection 0>X1) because no patent had been issued when an application was filed or approved, the holder shall file such information under this subsection not later than 30 days after the date the patent involved is issued. Upon the submission of patent information under this subsection, the Secretary shall publish it.". (2) The first sentence of section 512(d)(l) is amended by redesignating subparagraphs (G) and (H) as subparagraphs (H) and (I), respectively and by inserting after subparagraph (F) the following:

21 USC 360b.

Public information. 21 USC 360b.

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